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Straight insertion safety infusion setRelated Patent Categories: Surgery, Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.), Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin, Material Introduced Or Removed Through Conduit, Holder, Or Implantable Reservoir Inserted In Body, Body Entering Conduit Axially Movable Within Body Piercing Conduit While Former Is Disposed In The BodyStraight insertion safety infusion set description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070191772, Straight insertion safety infusion set. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The present invention relates generally to an infusion set, and more particularly to a low profile infusion set used for intermittent or continuous delivery of medication, such as insulin to a patient. BACKGROUND OF THE INVENTION [0002] Patients who receive intermittent or continuous doses of medication, such as insulin, via subcutaneous injection, often have an infusion set affixed to their skin in a convenient location. Keeping an infusion set fixed in place is discreet, and reduces the need for repeatedly puncturing the skin with a needle, thereby reducing the risk of infection as well as reducing the formation of scar tissue. The infusion set typically includes a housing supporting a tubular cannula with a removable injection needle at one end for penetrating the skin, and a septum at the other end for receiving a needle attached to a supply tube from a medicinal source, e.g., an insulin pump. One well-known conventional infusion set is a "straight set", in which the cannula and injection needle are inserted in an orientation substantially normal to the skin. The straight set requires a relatively short injection needle, which is less intimidating to some patients, and is relatively easy to insert through the skin. But, because the cannula and injection needle are supported to be oriented normal to the skin, the housing must be upright, conspicuous, and relatively bulky, and furthermore, the cannula, rigidly attached to a bottom of the housing can be subject to kinking and occlusion. [0003] Another known infusion set is a low profile angled set, in which the cannula and injection needle are supported in the housing to be oriented at an acute angle with respect to the skin. The housing of the low profile angled set is less bulky and is much more discreet than the housing of the straight set. However, because of the angled insertion, a much longer injection needle is required, and the longer needle is more intimidating and more difficult to insert, and is subject to inadvertent bending. [0004] Additional problems exist with both the conventional straight and angled sets. For example, a relatively long portion of cannula tubing is left exposed. A view of the injection site is often obscured. Adhesive mounting pads used on the sets can be awkward to use, often prematurely contacting the skin, causing wrinkling of the adhesive pad. Moreover, the needle or the cannula often touch non-sterile tissue or clothing prior to insertion, which increases the risk of infection. [0005] Another problem is that in infusion sets in which a self-adhesive pad is used to attach the unit to the skin, the self-adhesive pad must be well supported during insertion to avoid wrinkling the pad. If the user doesn't satisfactorily attach the pad to the skin without wrinkles, the infusion set may need to be removed and replaced. The user is more likely to have a problem applying and smoothing the adhesive pad with the needle/cannula already inserted since they must be careful not to dislodge the cannula. Furthermore, the insertion needle is usually left in place until the adhesive pad is completely attached and may cause pain or discomfort until it is removed. While a relatively small adhesive pad, that is just slightly larger than the infusion set base, would prevent the unsupported edges from drooping and prematurely contacting the skin, a smaller pad provides less adhesion and may allow the infusion set to become detached during use. SUMMARY OF THE INVENTION [0006] Accordingly, the present invention is directed to an infusion set that mitigates or substantially obviates one or more of the shortcomings caused by the limitations and disadvantages of the related art. [0007] The features and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by the apparatus, and the method of practicing the invention, particularly pointed out in the written description and claims below, as well as in the attached drawings. [0008] In accordance with an aspect of the invention, an infusion set assembly is provided with a multiple-part housing. A first portion or cannula housing is removably attachable to a surface of a user's skin. A second portion or septum housing is pivotally attached to the cannula housing, pivotable between a first position above the cannula housing and substantially normal to the surface of the skin and a second position alongside the cannula housing portion and substantially parallel to the skin surface. An elongated tubular cannula is provided, having a first end and a second end. An injection needle is removably mounted in the cannula and extends from the first end. The infusion set assembly is configured such that the injection needle and the first end of the cannula penetrate the skin surface at an injection site in an orientation that is substantially normal to the skin surface. After insertion of the cannula, the insertion needle is removed and the septum housing is pivoted to the second position. [0009] In accordance with another aspect of the invention, the cannula is initially supported by the insertion needle spaced from a bottom surface of the cannula housing. An adhesive assembly is provided on the bottom surface of the cannula housing for adhering the cannula housing portion to the skin. With the cannula initially maintained spaced from the adhesive surface, the user can fully attach the infusion set base and smooth the adhesive to the skin before the needle/cannula is inserted. If the adhesive pad is not satisfactorily attached or not smoothed without wrinkles, the infusion set can be removed without cannula/needle insertion. [0010] In accordance with yet another aspect of the invention, a disposable insertion guide housing portion is provided for supporting the cannula housing portion and the insertion handle portion above the injection site prior to injection, allowing the user to preposition the infusion set generally perpendicular to and above the skin surface at the injection site. The infusion set can be pre-packaged with the disposable insertion guide housing portion, ready to use, right off the shelf without needing to be assembled by the user. The guide housing portion also maintains the insertion needle hidden from view during the entire insertion process to lessen the user's anxiety, particularly in the case of children. [0011] In accordance with a further aspect of the invention, an insertion needle or solid trocar initially passes through the interior of the soft cannula such that its sharp cutting edges extend beyond the distal end of the cannula. The proximal end of the needle is attached to an insertion needle handle which is mounted within an insertion guide housing which positions and holds the needle and cannula distal end above the cannula housing. With the needle and cannula distal end spaced from the attachment surface, the cannula housing is attached to the skin at the insertion site on the skin. Thereafter, the insertion needle handle is pressed towards the skin such that the needle and cannula distal end are guided towards the cannula housing by the insertion guide housing. The needle and cannula distal end pass through the opening in the cannula housing, penetrate the skin, and are inserted perpendicularly into the tissue. The insertion needle is then withdrawn into the insertion guide housing leaving only the distal end of the cannula in the subcutaneous tissue. The insertion guide housing can then be removed and discarded with the insertion needle safely shielded inside. During the entire insertion process the insertion needle is never exposed. [0012] In accordance with a further aspect of the invention, the proximal end of the septum housing is pivoted approximately 90 degrees and latched to the main body of the cannula housing so as to prevent further rotation or movement. As the septum housing is pivoted, the portion of the cannula between the distal end of the septum housing and the opening in the base of the cannula housing is bent in a smooth arc over a mandrel on the cannula housing. The mandrel controls the bend radius of the cannula in the latched position to further prevent the cannula from kinking. Clearance between the cannula and opening in the main body allows the cannula to flex if the inserted cannula and the housing bottom are not perpendicular without kinking the cannula. Once the septum housing is latched, a needle hub assembly may be attached to the cannula housing assembly. [0013] In accordance with still another aspect of the invention, the septum housing supports the cannula and is initially detached from the cannula housing. Upon depression of the insertion needle handle, pivot pins on the septum housing engage mating pivot holes in the cannula housing. The pivot pins snap into the holes, pivotally interconnecting the septum housing to the cannula housing. [0014] In accordance with yet another aspect of the invention, the septum housing remains pivotally-attached to the cannula housing. The septum and cannula are mounted coaxially within a separate cannula cartridge which is mountable on the insertion needle with the needle extending from the cannula distal end. The cannula cartridge is initially mounted above and axially-aligned with a stepped bore in the septum housing. The axis of the stepped bore in the septum housing is aligned with the opening in the cannula housing and is perpendicular to the flat base of the cannula housing. When the insertion handle is pressed towards the skin, the cannula cartridge is advanced such that the cartridge enters the stepped bore of the septum housing, and the needle and cannula distal end pass through the opening in the bottom of the cannula housing penetrating the surface of the skin. As the handle is depressed, the cannula cartridge engages and is retained within the septum housing. After the insertion handle is retracted and removed, the septum housing can then be pivoted parallel to the surface of the skin and latched. [0015] It is to be understood that both the above general description and the following detailed description are exemplary and explanatory, and are intended to explain the principles of the claimed invention. The accompanying drawings are included to provide a further understanding of the invention and are incorporated and constitute part of the specification, illustrating presently preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0016] FIG. 1 is a perspective view of an infusion set assembly in accordance with a first exemplary embodiment of the invention; [0017] FIG. 2 is an exploded perspective view of the infusion set assembly of FIG. 1; [0018] FIG. 3 is a cross-sectional view along line 3-3 of FIG. 1; [0019] FIG. 4 is a cross-sectional view similar to FIG. 3 with the insertion handle depressed and the cannula fully inserted; [0020] FIG. 5 is a cross-sectional view similar to FIG. 4 with the insertion handle retracted after the cannula has been fully inserted; Continue reading about Straight insertion safety infusion set... Full patent description for Straight insertion safety infusion set Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Straight insertion safety infusion set patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. 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